Single use viable air monitoring in critical environments of a specialty multi-purpose contract manufacturing organization

Single use viable air monitoring in critical environments of a specialty multi-purpose contract manufacturing organization

04/17/2018, 2:30 PM - 3:15 PM

Technical Conference Stage 3, Booth 1376, Exhibit Hall

Language:
English

The absence of microbial contaminations is considered a critical quality attribute due to its potential to dramatically impact, directly or indirectly, the safety and/or the efficacy of the drug product. Specifically, for injectable drug products like antibiotics and cytostatics it becomes even more important as typical patients are immunocompromised. Under these aspects the selection of the best viable air monitoring methodology is a key aspect to consider. Due to some outdated sampling heads we were forced to reconsider our viable air sampling strategy. Risk assessments revealed as very important factors the potential for cross-contamination (of antibiotics & cytostatics) in our multi-purpose facility and of course the security of the process and the product. Other important factors were the cleaning validation and risk of the operators to the drug products due to the inherent toxicity of some products. Reducing the risk of false positive & false negative results were key selection criteria as well. This presentation will guide the audience through the selection process and will give a review after several months of usage, revealing a surprising view on the total return of investment of the overall solution.

Contributors

  • Maria Cristina Cozzolino

    Speaker

    Head of EM Monitoring

    Corden Pharma Latina S.P.A

  • Frank Panofen

    Speaker

    Dr

    Particle Measuring Systems GmbH

Type of Session

  1. Type of Session
    Session

Learning Objectives

  1. Learning Objectives 1. The attendees will learn how cross-contamination in multi purpose facilities can be reduced by the right viable air monitoring concept 2. Single use viable air monitoring systems help to reduce cleaning and disinfection efforts in critical environments, especially important when handling toxic API´s 3. How to reduce the false positive rate in environmental monitoring and increase the overall productivity

Categories

  1. Track
    Manufacturing Efficiencies & Improvements

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